Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Public Meeting, 19668-19669 [2015-08359]
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19668
Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices
Description: The federal Office of
Child Support Enforcement, Division of
Federal Systems, maintains the Child
Support Portal, which contains a variety
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enforce state child support cases. To
securely access the child support
applications, authorized users must
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DEPARTMENT OF HEALTH AND
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Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Federal Child Support Portal
Registration.
OMB No.: 0970–0370.
The federal Child Support Portal
Registration information collection
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to restrict access to confidential
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Locator Service to authorized persons,
and to restrict use of such information
to authorized purposes.
Respondents: Employers, Financial
Institutions, Insurers, and State
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ANNUAL BURDEN ESTIMATES
Number of
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Instrument
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respondent
183
1
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Registration Screens .......................................................................................................
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
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on the specific aspects of the
information collection described above.
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information can be obtained an
comments may be forwarded by writing
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Families, Office of Administration,
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DC 20447, Attn: ACF Reports Clearance
Officer. Email address infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
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whether the information shall have
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agency’s estimate of the burden of the
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the quality, utility, and clarity of the
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ways to minimize the burden of the
collection of information on
respondents, including through the use
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–08397 Filed 4–10–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–1082]
Preparation for International
Conference on Harmonization Steering
Committee and Expert Working Group
Meetings in Fukuoka, Japan; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
regional public meeting entitled
‘‘Preparation for ICH Steering
Committee and Expert Working Group
Meetings in Fukuoka, Japan’’ to provide
information and receive comments on
the International Conference on
Harmonization (ICH) as well as the
upcoming meetings in Fukuoka, Japan.
The topics to be discussed are the topics
for discussion at the forthcoming ICH
Steering Committee Meeting. The
purpose of the meeting is to solicit
public input prior to the next Steering
Committee and Expert Working Group
meetings in Fukuoka, Japan, scheduled
on June 6 through 11, 2015, at which the
discussion of the topics underway and
ICH reforms will continue.
DATES: The public meeting will be held
on May 15, 2015, from 1 p.m. to 4 p.m.
Registration to attend the meeting and
requests for oral presentations must be
received by May 11, 2015. See the
SUPPLEMENTARY INFORMATION section for
information on how to register for the
meeting.
SUMMARY:
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Average
burden
hours per
response
0.15
Total
burden
hours
27.45
The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, Great Room (Rm.
1503 A), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit either electronic or written
comments by June 14, 2015. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Tracy Porter, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1173, Silver Spring,
MD 20993, 301–796–7789, FAX: 301–
847–8443, email: tracy.porter@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
The ICH was established in 1990 as a
joint regulatory/industry project to
improve, through harmonization, the
efficiency of the process for developing
and registering new medicinal products
in Europe, Japan, and the United States
without compromising the regulatory
obligations of safety and effectiveness.
E:\FR\FM\13APN1.SGM
13APN1
Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for medical product
development among regulatory
Agencies. ICH was organized to provide
an opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. Members of the ICH
Steering Committee include the
European Union; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labor, and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; FDA; the Pharmaceutical
Research and Manufacturers of America;
Health Canada; Swissmedic; and the
World Health Organization (as an
Observer). The ICH process has
achieved significant harmonization of
the technical requirements for the
approval of pharmaceuticals for human
use in the ICH regions over the past two
decades.
The current ICH process and structure
can be found at the following Web site:
https://www.ich.org. (FDA has verified
the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
II. Meeting Attendance and
Participation
mstockstill on DSK4VPTVN1PROD with NOTICES
A. Registration
If you wish to attend the meeting,
visit https://www.eventbrite.com/e/
international-conference-onharmonization-regional-public-meetingtickets-16183519342. Please register for
the meeting by May 11, 2015. Seating
may be limited, so early registration is
recommended. Registration is free and
will be on a first-come, first-served
basis. However, FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the meetings
will be based on space availability.
If you need special accommodations
because of a disability, please contact
Tracy Porter (see FOR FURTHER
VerDate Sep<11>2014
18:02 Apr 10, 2015
Jkt 235001
INFORMATION CONTACT)
at least 7 days
19669
before the meeting.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
B. Requests for Oral Presentations
Food and Drug Administration
Interested persons may present data,
information, or views orally or in
writing on issues pending at the public
meeting. Public oral presentations will
be scheduled between approximately
3:30 p.m. and 4 p.m. Time allotted for
oral presentations may be limited to 5
minutes. Those desiring to make oral
presentations should notify Tracy Porter
(see FOR FURTHER INFORMATION CONTACT)
by May 11, 2015, and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present; the names and addresses,
telephone number, fax, and email of
proposed participants; and an
indication of the approximate time
requested to make their presentation.
The agenda for the public meeting
will be made available on the Internet
at https://www.fda.gov/Drugs/
NewsEvents/ucm439475.htm.
[Docket No. FDA–2014–D–0363]
III. Comments
Interested persons may submit either
electronic or written comments to the
public docket (see ADDRESSES) by June
14, 2015. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
IV. Transcripts
Please be advised that as soon as a
meeting transcript is available, FDA will
post it at https://www.fda.gov/Drugs/
NewsEvents/ucm439475.htm.
Dated: April 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–08359 Filed 4–10–15; 8:45 am]
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Expedited Access for Premarket
Approval and De Novo Medical
Devices Intended for Unmet Medical
Need for Life Threatening or
Irreversibly Debilitating Diseases or
Conditions; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of the
guidance entitled ‘‘Expedited Access for
Premarket Approval and De Novo
Medical Devices Intended for Unmet
Medical Need for Life Threatening or
Irreversibly Debilitating Diseases or
Conditions.’’ This guidance outlines
FDA’s new, voluntary program for
certain medical devices that
demonstrate the potential to address
unmet medical needs for life threatening
or irreversibly debilitating diseases or
conditions and that are subject to
premarket approval (PMA) applications
or de novo classifications. FDA believes
that the Expedited Access Pathway
(EAP) program will help patients have
more timely access to these medical
devices by expediting their
development, assessment, and review,
while preserving the statutory standard
of reasonable assurance of safety and
effectiveness for premarket approval,
consistent with the Agency’s mission to
protect and promote public health. The
document also discusses how the EAP
program approaches the balance of
premarket and postmarket data
collection and incorporates a benefitrisk framework. The EAP program will
become effective April 15, 2015.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Expedited Access
for Premarket Approval and De Novo
Medical Devices Intended for Unmet
Medical Need for Life Threatening or
SUMMARY:
E:\FR\FM\13APN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19668-19669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1082]
Preparation for International Conference on Harmonization
Steering Committee and Expert Working Group Meetings in Fukuoka, Japan;
Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
regional public meeting entitled ``Preparation for ICH Steering
Committee and Expert Working Group Meetings in Fukuoka, Japan'' to
provide information and receive comments on the International
Conference on Harmonization (ICH) as well as the upcoming meetings in
Fukuoka, Japan. The topics to be discussed are the topics for
discussion at the forthcoming ICH Steering Committee Meeting. The
purpose of the meeting is to solicit public input prior to the next
Steering Committee and Expert Working Group meetings in Fukuoka, Japan,
scheduled on June 6 through 11, 2015, at which the discussion of the
topics underway and ICH reforms will continue.
DATES: The public meeting will be held on May 15, 2015, from 1 p.m. to
4 p.m. Registration to attend the meeting and requests for oral
presentations must be received by May 11, 2015. See the SUPPLEMENTARY
INFORMATION section for information on how to register for the meeting.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, Great Room
(Rm. 1503 A), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit either electronic or written comments by June 14, 2015.
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Tracy Porter, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1173, Silver Spring, MD 20993, 301-796-
7789, FAX: 301-847-8443, email: tracy.porter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory obligations of safety and effectiveness.
[[Page 19669]]
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory Agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. Members of the ICH Steering Committee include
the European Union; the European Federation of Pharmaceutical
Industries Associations; the Japanese Ministry of Health, Labor, and
Welfare; the Japanese Pharmaceutical Manufacturers Association; FDA;
the Pharmaceutical Research and Manufacturers of America; Health
Canada; Swissmedic; and the World Health Organization (as an Observer).
The ICH process has achieved significant harmonization of the technical
requirements for the approval of pharmaceuticals for human use in the
ICH regions over the past two decades.
The current ICH process and structure can be found at the following
Web site: https://www.ich.org. (FDA has verified the Web site addresses
in this document, but FDA is not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.)
II. Meeting Attendance and Participation
A. Registration
If you wish to attend the meeting, visit https://www.eventbrite.com/e/international-conference-on-harmonization-regional-public-meeting-tickets-16183519342. Please register for the
meeting by May 11, 2015. Seating may be limited, so early registration
is recommended. Registration is free and will be on a first-come,
first-served basis. However, FDA may limit the number of participants
from each organization based on space limitations. Registrants will
receive confirmation once they have been accepted. Onsite registration
on the day of the meetings will be based on space availability.
If you need special accommodations because of a disability, please
contact Tracy Porter (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
B. Requests for Oral Presentations
Interested persons may present data, information, or views orally
or in writing on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 3:30 p.m. and 4
p.m. Time allotted for oral presentations may be limited to 5 minutes.
Those desiring to make oral presentations should notify Tracy Porter
(see FOR FURTHER INFORMATION CONTACT) by May 11, 2015, and submit a
brief statement of the general nature of the evidence or arguments they
wish to present; the names and addresses, telephone number, fax, and
email of proposed participants; and an indication of the approximate
time requested to make their presentation.
The agenda for the public meeting will be made available on the
Internet at https://www.fda.gov/Drugs/NewsEvents/ucm439475.htm.
III. Comments
Interested persons may submit either electronic or written comments
to the public docket (see ADDRESSES) by June 14, 2015. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov.
IV. Transcripts
Please be advised that as soon as a meeting transcript is
available, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm439475.htm.
Dated: April 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08359 Filed 4-10-15; 8:45 am]
BILLING CODE 4164-01-P
